Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection (Quilting)

October 21, 2020 updated by: Lindenhofgruppe AG

Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection in Patients With Breast Cancer: a Single Blind Randomised Phase III Controlled Trial

Breast cancer is the most frequent type of cancer among Swiss women (5'700 cases diagnosed every year). Mastectomy is indicated when breast conservative surgery is not possible or by patient wish. Axillary lymph nodes dissection (ALND) is indicated primarily for node-positive breast cancer.

Postoperative seroma after mastectomy and axillary clearance is a common complication, occurring in 25 to more than 60% of patients with breast cancer. After mastectomy and/or ALND conventional wound closure commonly uses suction drain to prevent seroma. However, seroma frequently occurs after drain removal. Excessive fluid accumulation in seroma stretches the skin, resulting in patient discomfort, impaired ipsilateral shoulder function and higher risk of surgical site infection and prolongs the hospitalization. In rare cases, a fibrous encapsulated seroma is resistant to conservative treatment and requires surgical resection. Thus, seroma may also impact health care costs requiring longer hospital stay or unplanned outpatient visits and may delay adjuvant therapy.

Recent data suggest that quilting suture through flap fixation reduces the incidence of seroma. Therefore, quilting suture has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and to reduce hospital costs, providing the rationale for this study.The aim of our project is to compare the efficacy of quilting suture with that of conventional closure without quilting in reducing the drainage quantity, the length of hospitalisation and the prevalence of seroma following mastectomy and/or axilla for breast cancer, as well as the patient reported pain increasing patient quality of life.

The final goal is the omission of axillary drainage in the future. All randomised patients will be followed for 12 weeks. Patients will fill in 2 questionnaires (EQ5-D: European Quality of Life and Brief Pain Inventory: BPI). The Health Economic Analysis form (HEA) will be completed by the investigator collecting the patient data.

Total duration of study: 2.5 years. There are 2 treatments groups 50% of the study participants will be treated with quilting suture and 50% with conventional closure. Patients are randomly divided into the 2 groups. All patients are blinded to the surgical treatment.This means that they do not know which surgical treatment they have received (quilting suture or conventional closure), The operating surgeon will not see the after the operation. Seroma assessment will be performed by other medical personnel, that do not know which surgical treatment has been given. In case of seroma a physician (not the operating surgeon) will perform the aspiration of seroma if needed.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the most frequent type of cancer among Swiss women (5'700 cases diagnosed every year). Mastectomy is indicated when breast conservative surgery is not possible or by patient wish. Axillary lymph nodes dissection (ALND) is indicated primarily for node-positive breast cancer.

Postoperative seroma after mastectomy and axillary clearance is a common complication, occurring in 25 to more than 60% of patients with breast cancer. After mastectomy and/or ALND conventional wound closure commonly uses suction drain to prevent seroma. However, seroma frequently occurs after drain removal. Excessive fluid accumulation in seroma stretches the skin, resulting in patient discomfort, impaired ipsilateral shoulder function and higher risk of surgical site infection and prolongs the hospitalisation. In rare cases, a fibrous encapsulated seroma is resistant to conservative treatment and requires surgical resection. Thus, seroma may also impact health care costs requiring longer hospital stay or unplanned outpatient visits and may delay adjuvant therapy.

Recent data suggest that quilting suture through flap fixation reduces the incidence of seroma. Therefore, quilting suture has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and to reduce hospital costs The aim of this trial is to compare the efficacy of quilting suture of the dead space at the pectoral area and/or axilla with that of conventional suture in reducing the total volume of post-mastectomy and/or axillary drainage and seroma in female patients after surgical treatment of breast cancer.The study seeks primarily to determine if quilting suture compared to conventional suture after mastectomy/ALND reduces the total volume of axillary drainage until drain removal.

This single blind randomised phase III controlled superiority trial compares 2 surgical techniques: quilting suture and conventional suture. Patients will be assigned to one of 2 parallel groups: Arm A: quilting suture and Arm B: (no quilting suture): conventional wound closure.

Duration of accrual: 2 years - Duration of trial treatment: 1 day (surgery). Surgery procedure: Mastectomies or ALND dissections using a standardized technique, with multiple quilting sutures in the site of the mastectomy/in the dissected axilla or conventional closure without quilting. In both procedures placement of one drain into the breast and axilla or in the axillary cavity.

All randomised patients will be followed for 12 weeks. Patients will fill in 2 questionnaires (Quality of Life: EQ5-D and Brief Pain Inventory: BPI). The Health Economic Analysis form (HEA) will be completed by the investigator collecting the patient data.

At the study visits the following examinations will be performed: physical examination, blinded assessment of seroma, axillary drain volume, adverse events and surgical site infections.

The sample size is based on the primary endpoint, the total volume of axillary drainage. We assume a reduction in the total volume of axillary drainage of 200 ml in the intervention arm (application of quilting sutures) compared to the control arm (no application of sutures), which is based on literature and actual measurements in 14 patients. A total of 106 patients (53 in each group) will yield a power of 80% to detect this difference at a two-sided significance level of 0.05.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3012
        • Brustzentrum Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ≥18 years-old female patients
  • mastectomy alone, mastectomy and sentinel, mastectomy and axilla, axilla and tumorectomy or axilla alone
  • patients with histo- or cytology proven breast cancer Union for International Cancer Control's (UICC)/American Joint Committee on Cancer (AJCC) stage I-III
  • Fluency in either German or French
  • The EQ-5D and BPI questionnaires must be completed by the patient at registration
  • Patient has given written informed consent before registration.

Exclusion Criteria:

  • Bilateral operation or reconstruction
  • Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent and/or filling out the questionnaires
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
quilting
Procedure: quilting
After mastectomies or ALND dissections using standard technique for wound closure multiple sutures (monocryl 3.0) every 3 to 4 cm in the site of the mastectomy (1 or 2 rows) or in the dissected axilla.Placement of one drain into the breast and axilla or in the axillary cavity by a separate stab incision
Active Comparator: Arm B
conventional suture
Procedure: conventional suture
After mastectomies or ALND dissections standard technique for wound closure. Placement of one drain into the breast and axilla or in the axillary cavity by a separate stab incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total volume (ml) of axillary/breast drainage until drain removal.
Time Frame: up to 5 days
Blinded daily measurement of axillary drainage volume during hospital stay at 8.00 h a.m in the morning through nurses.
up to 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total duration (days) of breast/axillary drainage
Time Frame: 1-5 days
calculated from the date of surgery to date of drain removal calculated drainage from the date of surgery to the date of axillary/breast drain removal
1-5 days
Duration of postoperative hospital stay
Time Frame: 5-7 days
calculated from the date of surgery to the date of discharge (after surgery patients are hospitalized usually for 5 days)
5-7 days
Number of patients with clinically relevant seroma
Time Frame: From the date of surgery until 12 weeks after surgery
Clinically relevant seroma is defined as either causing strong discomfort or requiring aspiration
From the date of surgery until 12 weeks after surgery
Number of patients with lymphedema
Time Frame: From the date of surgery until week 12
increase of more than 2.5 cm in arm circumference
From the date of surgery until week 12
Adverse Events (AEs) due to surgical procedure
Time Frame: during 4 weeks after surgery
after surgery possible wound-related complications (e.g. haematoma requiring reoperation, skin flap necrosis) flap necrosis)
during 4 weeks after surgery
Surgical morbidity
Time Frame: within the 12 weeks follow up after surgery
number of outpatient visits (related to mastectomy/ALND) needed following participant's discharge
within the 12 weeks follow up after surgery
Duration (number of days) of clinically relevant seroma aspiration period
Time Frame: from the date of surgery until 12 weeks after surgery
calculated until the date of the last clinically relevant seroma aspiration
from the date of surgery until 12 weeks after surgery
Volume of axillary drainage per 24 hours in ml
Time Frame: up to 5 days
calculated as the total volume of axillary drainage in ml until drain removal divided by the total duration of axillary drainage in days
up to 5 days
Number of clinically relevant seroma aspirations
Time Frame: From the date of surgery until 12 weeks after surgery
Aspiration is performed if the patient experiences strong discomfort, in case of impaired ipsilateral shoulder function, if higher risk of surgical infection and in case pain interferences with daily functions
From the date of surgery until 12 weeks after surgery
Total volume in ml of all clinically relevant seroma aspirations
Time Frame: From the date of surgery until 12 weeks after surgery
calculated in in ml
From the date of surgery until 12 weeks after surgery
Surgical morbidity
Time Frame: up to 2 hours
intraoperative blood loss calculated in ml from start to end of surgery
up to 2 hours
Surgical morbidity
Time Frame: up to 2 hours
duration of the surgical procedure from start to end of surgery
up to 2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient self-reported pain will be assessed with the Brief Pain Inventory (BPI) patient self-reported questionnaire
Time Frame: every day during the first 2 weeks after the operation and at week 4 and 12 after surgery
This questionnaire is a well validated and commonly used self-report measure to assess the severity of pain and the interference of pain with daily activities as well as the quality of life, patient's subjective experience of disease and treatment. The BPI assesses pain at its "worst," "least," "average," and "now" (current pain) on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) during the past 24 hours A clinically meaningful change in worst pain is defined as a change from baseline of at least 2 points in either direction. The BPI measures how much pain has interfered general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. This mean can be used if more than 50% or four of seven of the total items have been completed on a given administration.
every day during the first 2 weeks after the operation and at week 4 and 12 after surgery
Patient Euro quality of life questionnaire (EQ-5D)
Time Frame: every day during the first 2 weeks after the operation and at week 4 and 12 after surgery

EuroQol Group developed the questionnaire to describe and value health-related quality of life patient's subjective experience of disease and treatment. This includes 5 assessments: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each assessment has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient ticks the box against the most appropriate statement in each of the 5 dimensions, which are summed in a 5-digit number describing the respondent's health state: having no problems for 1, slight problems for 2, moderate problems for 3, severe problems for 4 and extreme problems for 5.

On the form there is also a scale with numbers from 0 to 100. 100 is the best health and 0 the worst health the patient can imagine. The patient has to tick the appropriate number.
every day during the first 2 weeks after the operation and at week 4 and 12 after surgery
Health Economic Analysis (HEA)
Time Frame: at week 4 and week 12
forms are completed by the investigator and collect data on hospitalizations, rehabilitation, stays at nursing homes, out-patient visits performed by physicians working at practice offices or at hospitals, treatments as physiotherapy,nutrition counseling or alternative therapies
at week 4 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lindenhofgruppe AG

Collaborators

University of Bern
StiftungLindenhof

Investigators

  • Principal Investigator: Gilles Berclaz, Brustzentrum Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BZ01/17
  • 17-17-F (Other Identifier: StiftungLindenhof)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The Clinical Trial Unit of the University of Bern will perform the statistical analysis and will be involved in the publication

IPD Sharing Time Frame

3 years after study end

IPD Sharing Access Criteria

3 years after study end

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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